Prosthetic devices for practicing augmentation mamoplasty conventionally are of two types: implants made of a silicone elastomer shell filled with a polymerized silicone gel, or silicone breast implants made of a silicone elastomer shell containing a valve which is filled with saline or other physiologic solutions. Neither type of device has been entirely successful, both experiencing early or late fluid or gel leakage through the shell, the leakage being more common in the fluid-filled implants but more dangerous for the gel-filled implants. With leakage from the gel-filled implant there is a chance for morbidity with gel extravasation in human tissue, and some silicon gel polymers are small enough to bleed through the elastomer shell. For these reasons, and also because various drugs (such as corticosteriods) can be added to the fluid-filled implants which might improve breast softness, and breast prenchyma can be studied easier by mammograms if implants are fluid-filled rather than gel-filled, fluid-filled implants are desirable.
Previous attempts have been made to solve some of the problems of conventional gel-filled implants by the creation of a two-chamber implant including an inner chamber containing silicone gel and an outer chamber which is filled with physiologic fluid via a self-sealing valve in the operating room. Such attempts have been described in an article entitled "Specific Applications of the Double Lumen Prosthesis" by John H. Hartlye, Jr., M.D., "Clinics and Plastic Surgery" Vol. 3, No. 2, pages 247-263 (April, 1976). The outer chamber is the fluid-filled chamber, and it can be deflated by percutaneous needle puncture if the breast becomes too firm as a result of capsule contracture. While such an approach can be successful, the problem of mammographic obliteration is still present.
According to the present invention a breast prosthesis, and a method of practicing augmentation mamoplasty utilizing the breast prosthesis, are provided which overcome many of the drawbacks associated with prior art prosthesis and techniques. An unfilled implant according to the present invention may be inserted more easily and through a smaller incision than conventional prefilled (or partially prefilled) implants. The breasts prosthesis according to the present invention comprises an outer inflatable container of flexible biological implant material (e.g. a silicone elastomer shell); an inner inflatable container of flexible biological implant material, substantially concentric with the outer container; and a self-sealing or operator sealed valve associated with each container and for admitting fluid to the container with which it is associated, and for sealing the fluid within the container after filling thereof. When self-sealing valves are used, they can be of any conventional type such as shown in U.S. Pat. Nos. 3,853,832 or 3,919,724, or such as those manufactured by Heyer-Schulte, Inc. The prosthesis also preferably comprises removable fluid-filling means for penetrating the self-sealing valves and providing the introduction of fluid therethrough.
Two different embodiments of the prosthesis may be provided. In one embodiment, the removable fluid-filling means comprises a single tubular member penetrating both self-sealing valves at the same time, with mounting means being provided for mounting the tubular member for movement from a position penetrating both self-sealing valves to a position penetrating only the self-sealing valve of the outer container, to a position penetrating neither valve. A mounting means preferably comprises a perforated tubular member having a diameter slightly larger than the diameter of the tubular member extending between the self-sealing valves and operatively connected thereto.
In the second embodiment, the removable fluid filling means comprises a pair of tubular members, one associated with each of the self-sealing valves, for penetrating a respective self-sealing valve, each of the tubular members extending to the exterior of the outer container. The inner container is connected to the outer container at one of the self-sealing valves which valve is common to the inner and outer containers.
In both embodiments, the inner and outer containers are preferably filled with physiologic fluid, such as saline or saline including corticosteriods.
The method of augmentation mamoplasty according to the present invention includes forming an incision in the breast area, and placing the prosthesis, preferably with both containers deflated, through the incision beneath the breast. Then one of the containers (preferably the inner container) is filled with a physiologic fluid and the self-sealing valve associated with that container is allowed to seal the fluid within the container. Then the other container (the outer container) is filled with the physiologic fluid, allowing the self-sealing valve associated with that container to seal the fluid within that container, and then the incision is closed.
It is the primary object of the present invention to provide an advantageous breast prosthesis and a method utilizing the same in augmentation mamoplasty. This and other objects of the invention will become clear from an inspection of the detailed description of the invention, and from the appended claims.